Is typical JJ comment/thesis/stance
about research supported in this article's cynical tone/content ?
Anyhow, my interpretation of this article is that reality is
.....absurdism, "fraudism."
Objectivists & libertarians will applaud, because this is their
philosophical
holding about government, isn't it?
Re-read this attack/article and cry/laff--whatever your preference.
http://www.tnr.com/doc.mhtml?i=20061030&s=lenzer103006
NIH Secrets.
Study Break
by Jeanne Lenzer
Post date 10.24.06 | Issue date 10.30.06 Discuss this article (1)
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t's not news that the pharmaceutical industry routinely suppresses
negative data, with the effect of exaggerating the benefits of its
drugs and glossing over their risks. Take, for example, the painkiller
Vioxx. According to court testimony, the drug's manufacturer, Merck,
withheld data showing that the drug caused five times as many heart
attacks as a similar painkiller, naproxyn. The result? Food and Drug
Administration (FDA) safety expert David Graham calculated that Vioxx
caused an estimated 39,000 to 60,000 heart-attack deaths before it was
pulled from the market in 2004. Or take the example of the
anti-depressants known as ssris, which include Prozac and Paxil. Recent
analyses of several papers touting the benefits of the drugs for
children found that the authors had accentuated the positive and
downplayed the negative. It was only when the FDA analyzed all the
data, in a 2004 study that was initially suppressed, that it was
discovered that taking the drugs doubled the risk of suicide for young
people.
Thank goodness these secretive, corporate drug trials are
counterbalanced by taxpayer-funded studies at the National Institutes
of Health (NIH), whose results are open to public scrutiny, right?
Actually, wrong. You would think that, because taxpayers paid for the
studies, the data ought to be available for independent verification.
But that's not how it actually works. When several leading researchers
contacted me, frustrated because they couldn't obtain data from
NIH-funded studies, I filed Freedom of Information Act (foia) requests
for the data they were unable to obtain. My foia requests were denied.
Indeed, despite a 1999 law clearly stating that such information should
be available to the public, it appears that no data have ever been
released under the law. And the price for that secrecy may be paid in
American lives.
he use of steroids to treat spinal-cord injuries offers a sobering
example. In late March 1990, the NIH announced, with great fanfare, the
results of the Second National Acute Spinal Cord Injury Study (nascis
2), a 487-person trial that appeared to show that high-dose steroids
reduced paralysis caused by acute spinal cord injury. Underscoring the
urgency of its results, the NIH issued an unprecedented prepublication
press release. This was followed by a "Dear Doctor" letter, which was
faxed to emergency departments across the nation, instructing
physicians in the correct dosing of steroids for patients with such
injuries. Given what was at stake, the NIH's actions appeared to be
warranted. Each year, approximately 10,000 people, most of them young
and healthy, suffer spinal-cord injuries in car accidents, falls, or
shootings. If, as nascis 2 suggested, steroids helped prevent paralysis
in these cases, it heralded a significant advance in treating people
who might otherwise spend their lives on breathing machines and in
wheelchairs. The "Dear Doctor" letter ensured that emergency-room
physicians would make high-dose steroids the standard of care for
victims of spinal-cord injuries.
But not all doctors were as enthusiastic about high-dose steroids as
the NIH. Fred H. Geisler, a neurosurgeon with the Illinois Neuro-Spine
Institute, had seen not only patients treated with steroids who failed
to improve, but also patients who got worse and died--not from their
injuries, but from the side effects of the steroids, such as
overwhelming infections and gastrointestinal bleeding. Geisler was
surprised by the NIH claims, but he knew enough to wait for the
published paper so that he could go over the data himself. When the
report was published in The New England Journal of Medicine, six weeks
after the NIH announcement, it did nothing to allay his doubts. Instead
of reporting on all the subjects included in the study, as is
customary, the authors wrote up the outcomes on only a subset of
patients.
Geisler knew the only way he could confirm his suspicions, or lay them
to rest, would be to reanalyze the raw data from the study. But the
lead author of nascis 2, Michael Bracken of the Yale School of Public
Health, refused to release the study data to Geisler and to other
critics despite multiple requests. After being contacted by some of
these critics in 2003, I filed a formal foia request with the NIH for
the data. The NIH directed me to Bracken and Yale, saying they did not
possess the data. I then requested the data from Bracken and,
separately, from Yale. Both denied my requests.
Lacking access to the data underlying the nascis 2 claims, most doctors
feel obligated to prescribe steroids as the "standard of care." But
it's a standard of which many are skeptical. On May 5, 2004, for
instance, more than 1,000 neurosurgeons gathered at the annual meeting
of the American Association of Neurological Surgeons in Orlando,
Florida, to hear a debate between Bracken and Geisler on high-dose
steroids. An electronic poll of the audience showed that, prior to the
debate, only 21 percent of the neurosurgeons present believed that
steroids lead to a significant improvement in outcome (compared with 48
percent who said it didn't improve outcome and 31 percent who responded
"don't know"). After the debate, those who said steroids improved
outcome dropped from 21 percent to 11 percent, and a mere 6 percent
said it ought to be the standard of care. Nonetheless, when asked if
they would personally prescribe high-dose steroids for patients with
acute spinal cord injuries in the future, 60 of the surgeons present
said they would. When asked why, 11 percent said they believed it
improved outcome, 31 percent claimed they feared litigation, and 38
percent said there was no better alternative.
The concerns of skeptics like Geisler were recently amplified when the
results of another study, known as the crash trial, were announced. The
study compared patients with serious brain injuries who were treated
with steroids with those treated with a placebo. For every 100 patients
treated with steroids, three more patients died than did patients
treated with the placebo. From these results, Geisler estimates that
5,000 people with spinal-cord injuries have already died from treatment
with high-dose steroids--and that stopping steroid treatment could save
300 lives per year in the United States.
Nor is Geisler alone in his concerns. Karim Brohi, a British trauma
surgeon at the Royal London Hospital, concurs: "Patients around the
world are suffering due to the inappropriate reporting and application
of this data," he says. "I believe it is highly questionable that
Bracken should be refusing to release the original data given the
potential associated morbidity and mortality associated with high-dose
steroids." Perhaps the most surprising support for Geisler's views
comes from an unexpected source: William Collins, a now-retired Yale
neurosurgeon who was Bracken's co-principal investigator on nascis 2.
Collins says he broke with Bracken and withdrew his name from the third
trial in the series in protest because "[Bracken] was always trying to
find something that I couldn't find"--i.e., a clinical benefit from
steroid treatment.
Nor is this a unique case of taxpayer-funded research being kept
hidden. In 2004, an NIH-sponsored study was reported to show that
Prozac was effective in treating depressed teenagers. But the NIH and
the study authors have refused to release the data in response to foia
requests--requests, significantly, that were made while Congress and
the FDA were holding hearings on the safety of antidepressants. In
another NIH study, published in 2003, researchers reported that the
brains of children with attention-deficit hyperactivity disorder (adhd)
were smaller than those of children who had not been diagnosed with the
disorder. Critics questioned whether the problem might actually be
caused by the drugs used to treat adhd. But, when a researcher asked
for the underlying data, his request was denied.
his isn't how it was supposed to be. The Shelby Amendment, passed in
1999, specifically directs federal agencies to "ensure that all data"
from federally funded research are "made available to the public
through the Freedom of Information Act." The NIH, in its data-sharing
guide known as Circular A-110, asserts that data-sharing "is essential
.... to improve human health."
Although the NIH officially encourages data-sharing, adherence to the
policy is voluntary. It is ultimately left to the individual researcher
or research institution to decide whether or not to share their data.
As Norka Ruiz-Bravo, NIH Deputy Director for Extramural Research,
acknowledged, "Some people share their toys better than others." But
the explanation for why so much NIH data are kept under wraps may be
more serious than that. Data secrecy is becoming the norm rather than
the exception, in an era when researchers--even those who have public
funding--are increasingly likely to have commercial interests to
protect.
According to a 2003 survey of 171 universities that received NIH grants
by the then-General Accounting Office, 91 percent held equity options
in the very companies for which they were developing technologies. Some
academic institutions receive over $10 million in royalties per year
for technologies they have developed. And individual
researchers--including some who have refused to release their data in
response--have also received funding from sponsoring drug companies.
These commercial ties, and the secrecy they spawn, have real
consequences for physicians who must rely on research results that may
not be entirely disinterested.
It is difficult to know how many dangerous treatments might remain on
the market, unchallenged, because of data secrecy. In the case of
Prozac for teens, the data withheld by researchers could show that
Prozac is not safe for children--an important development, given that
it is currently the only anti-depressant approved by the FDA for the
treatment of children. In the case of the study showing that the brains
of children with adhd are smaller, it means that stimulant drugs
continue to be prescribed even though it is not clear whether brain
shrinkage in children with adhd is caused by the disease--or by the
drugs used to treat the disease.
Wondering how widespread the problem of NIH secrecy was, I reviewed the
data-sharing exemptions in Circular A-110 and all extramural grants
awarded by the NIH in 2005. What I found was that, despite the lofty
claims of data-sharing, there are so many exemptions in the guide and
the Shelby Amendment that they actually serve to codify data secrecy.
For example, only researchers conducting studies that cost more than
$500,000 in direct costs annually are required to file a data-sharing
plan. Data are also exempt if they are not cited as part of a federal
policy or regulation that has the "force and effect of law"--an
exclusion that single-handedly eliminates virtually all NIH data. After
reviewing all of the grants awarded by the NIH during 2005 and finding
that virtually none of the data would fall under the conditions of
mandatory release, I asked the NIH to identify any studies that had
been released under the Shelby Amendment. Their answer was surprisingly
frank: I was told that, "despite numerous requests" for data since the
Shelby Amendment was passed in 1999, "none met the criteria of the
regulation."
Jeanne Lenzer is a freelance medical investigative journalist and a
Knight Science Journalism Fellow at MIT.
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